Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Over 19 Pharmaceutical / Industry UNMC-260-00 GENITOPE-IND-8294, NCT00006478

Objectives

1. Determine the humoral and cellular immune responses in patients with follicular non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with keyhole limpet hemocyanin plus sargramostim (GM-CSF).
2. Determine the safety and toxicity of this regimen in these patients in the post-transplant setting.
3. Determine the changes in quantitative bcl-2 in the blood and bone marrow of these patients before and at various times after the series of idiotype vaccines.

Entry Criteria

Disease Characteristics:

• Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that failed induction therapy



• Previously received no more than 2 high-dose chemotherapies before hematopoietic stem cell transplantation



• Minimal disease state at day 100 to 6 months post-transplantation
  • Lymph nodes smaller than 2 cm
  • Less than 20% bone marrow involvement with lymphoma
  • Uncertain complete remission, defined by greater than 75% reduction in the size of the pre-transplantation mass not representing active disease



• Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy
  • Must have adequate circulating lymphoma cells

Prior/Concurrent Therapy:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Patient Characteristics:

Age:

• Over 19

Performance status:

• Karnofsky greater than 70%

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics
• Absolute neutrophil count greater than 1,000/mm³*
• CD4+ count greater than 200/microliter*

 [Note: *No restrictions if study vaccine administered at 6 months after transplantation]

Hepatic:

• Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)
• SGOT and SGPT less than 2 times normal (unless due to lymphomatous involvement)

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation

Expected Enrollment

A total of 20 patients will be accrued for this study.

Outcomes

Humoral and cellular immune response
Safety
Toxicity
Changes in quantitative bcl-2 levels

Outline

Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth and final dose.

Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Julie Vose, MD, Protocol chair		Ph: 402-559-3848 Email: jmvose@unmc.edu

Registry Information
Official Title		Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
Trial Start Date		2000-09-22
Trial Completion Date		2008-04-03
Registered in ClinicalTrials.gov		NCT00006478
Date Submitted to PDQ		2000-09-14
Information Last Verified		2008-08-14
NCI Grant/Contract Number		CA36727

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